Sleep Disorder in Inflammatory Bowel Disease and Its Association With Disease Activity

Last updated: November 27, 2023
Sponsor: Mahidol University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Disorders

Insomnia

Restless Leg Syndrome

Treatment

N/A

Clinical Study ID

NCT05536817
SI101/2021
  • Ages > 18
  • All Genders

Study Summary

Recently, an association between active inflammatory bowel disease (IBD) and poor sleep quality has been proposed; however, the causal relationship has not yet been established. This study aimed to investigate prevalence of poor sleep quality in IBD and association with disease activity by subjective and objective measures.

Prospective observational study is conducted with expected sample size of 100 patients. Participants are classified into active and inactive disease status according to standard IBD severity assessment measures. Demographic data, disease activity, quality of life, sleep questionnaire (validated PSQI questionaire), and seven-day sleep data acquired from ambulatory wrist actigraphy were obtained. Association between sleep quality and disease activity will be analyzed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years
  • Diagnosed inflammatory bowel disease, followed up in Siriraj hospital, MahidolUniversity

Exclusion

Exclusion Criteria:

  • Unstable medical conditions
  • Known psychiatric disease
  • Patients who could not withhold sedative drugs
  • Pregnant patients
  • Obese patients with body mass index (BMI) ≥ 35 kg/m2
  • Refuse to sign a consent/ had cognitive impairment

Study Design

Total Participants: 100
Study Start date:
February 05, 2021
Estimated Completion Date:
February 29, 2024

Connect with a study center

  • Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University

    Bangkok, 10700
    Thailand

    Active - Recruiting

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